Percutaneous access

ABSTRACT

Medical devices and related methods enable physicians and/or other medical personnel to access percutaneously the interior of a patient. One particular device includes a housing which defines a cavity, a first opening into the cavity, and a second opening into the cavity. The housing is implantable in a patient. The cavity is placed subcutaneously within the patient. The first opening is substantially flush with the surface of the skin of the patient and creates a percutaneous passageway from the exterior of the skin of the patient into the cavity, and the second opening creates a passageway from the cavity into the interior of the patient. A connector is coupled to the second opening and disposed substantially within the cavity to enable a connection between a first device and a second device disposed within the interior of the patient.

The present application is a continuation of application Ser. No.10/462,464, filed Jun. 16, 2003 now U.S. Pat. No. 6,758,841 which is adivisional of application Ser. No. 09/896,822, filed Jun. 29, 2001 nowU.S. Pat. No. 6,607,504, both of which are entitled “PercutaneousAccess”.

TECHNICAL FIELD

The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.

BACKGROUND INFORMATION

Long term access to a patient's bloodstream (longer than one month, forexample) is required for many medical treatments including antibiotictherapy, hemodialysis access, chemotherapy regimens, and othertreatments that require repeated infusion or blood processing. In somecases, internal access to the patient is required for years. Currentdevices and methods generally negatively impact the quality of thepatient's life, and the patient sometimes develops complications as aresult of the long term access. Vascular access devices used for longerterm treatments include tunneled central catheters (including dialysiscatheters), implanted infusion ports (including dialysis ports),dialysis grafts, and fistulas. A cuffed catheter can be used fornon-vascular access, such as to the abdominal cavity for peritonealdialysis to prevent infection.

Tunneled catheters can cause infection of the bloodstream or peritoneumand the skin entry site. The external portion of the catheter canfracture or otherwise fail due to its movement after placement. Also,the placed catheter can be accidentally or intentionally removed fromthe body, causing the patient pain and other complications. There isalso the possibility of increased wear, damage, or disassembly caused bythe patient “playing with” the placed device. The skin entry siterequires constant maintenance and clamps are required to preventbleeding through the catheter and to prevent air embolus. The portion ofthe catheter external to the patient's body frequently is uncomfortablefor the patient. The external catheter and the skin entry site canprevent the patient from bathing normally or engaging in normal physicalactivities.

Subcutaneously implanted access ports require the use of needles toaccess the port through the patient's skin. Using needles, such as thelarge needles used for dialysis ports, creates the potential forinfection and causes the patient pain. The access port reservoir has thepotential of accumulating debris and harboring infection. In the eventan internally-connected catheter connecting to this type of port needsto be replaced, a surgical procedure is required.

Grafts and fistulas on the patient's arm are disfiguring, and theyrequire frequent access with large bore needles which causes pain andeventually destroys the access route. Grafts and fistulas also requireinvasive vascular surgery to be created and revised. Additionally,interluminal declotting is often necessary.

With respect to medical devices that are permanently implanted into apatient, such as a pacemaker for example, access is limited to surgicalmeans in order to reach the device to replace batteries or repaircomponents. Electrical leads that pass through the skin to supply powerand control for the internally-implanted device can cause infection.

SUMMARY OF THE INVENTION

The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.In one embodiment, an access device allows physicians and other medicalpersonnel to obtain long term percutaneous access to a patient's body.The access device reduces the opportunity for infection by completelyshielding fluid connections (that extend into the interior of thepatient's body) from the patient's skin and from the externalenvironment. The access device has no protruding external elements, andcan be protected by a low-profile cover that is substantially flush withthe patient's skin. The access device thus is cosmetically appealing andallows substantially normal physical activity. The cover is difficult toremove accidentally or intentional from the access device. The accessdevice allows access to the interior of the patient without requiring aneedle to pierce the skin. Further, internal components, such as acatheter or a valve, can be replaced without a surgical procedure.

In one aspect, the invention involves a medical device. The medicaldevice includes a housing defining a cavity, a first opening into thecavity, and a second opening into the cavity. The housing is implantablein a patient to dispose the cavity subcutaneously within the patient.The first opening is substantially flush with the surface of the skin ofthe patient and creates a percutaneous passageway from the exterior ofthe skin of the patient into the cavity. The second opening creates apassageway from the cavity into the interior of the patient. The medicaldevice further includes a connector coupled to the second opening anddisposed substantially within the cavity and allows for a connectionbetween a first device and a second device disposed within the interiorof the patient. In one embodiment, the housing defines a flange forextending subcutaneously into the patient to anchor the housing in thepatient.

In another embodiment, the medical device further includes a cover thatis removably couplable to the housing. The cover selectively seals andexposes the first opening and is cover substantially coplanar with thesurface of the skin of the patient when sealing the first opening. Thecover is removable to allow the first and second devices to be connectedvia the connector. The cover includes a locking mechanism to prevent thecover from being inadvertently removed. In other embodiments the coveris canoe or elliptically shaped. In one embodiment, the cover furtherincludes an electrical connector. In another embodiment, the coverfurther includes a display.

In yet another embodiment, the connector includes a luer connector. Inother embodiments, the medical device further includes a valve. In stillother embodiments, the medical device further includes a cap removablycoupled to the luer connector to selectively seal and expose the luerconnector. The cap removably couples to the luer connector with athreaded connection. In some embodiments, the luer connector istelescopic and capable of being extended out of the cavity when thecover is removed from the first opening. In other embodiments, the luerconnector includes a pivoting luer connector which opens a fluid paththrough the second opening when pivoted to a first position and sealsthe fluid path through the second opening when pivoted to a secondposition. In yet another embodiment, the connector includes anelectrical connector. In another embodiment, the connector is releasablycouplable to the second opening.

In still another embodiment, the first device includes a connection tubeand the second device includes a catheter. The catheter includes asingle lumen catheter a multilumen catheter.

In one embodiment, the first device includes an infusion device forinfusing medication into the patient. In another embodiment, the firstdevice includes a device for removing bodily fluids of the patient. Instill another embodiment, the first device includes a device forremoving, purifying, and reintroducing blood into the patient.

In another embodiment, the connector includes an electrical-connector.In one embodiment, the electrical connector is releasably couplable to abattery disposable entirely within the cavity for supplying power to thesecond device. In another embodiment, the electrical connector isreleasably couplable to a control device disposable entirely within thecavity for supplying control signals to the second device.

In another aspect, the invention relates to a method of obtainingpercutaneous access to the interior of a patient. The method includesmaking a straight incision in the patient and implanting in the patientthrough the straight incision a medical device. The medical deviceincludes a housing defining a cavity, a first opening into the cavity,and a second opening into the cavity. The housing is implantable in apatient to dispose the cavity subcutaneously within the patient. Thefirst opening is substantially flush with the surface of the skin of thepatient and creates a percutaneous passageway from the exterior of theskin of the patient into the cavity. The second opening creates apassageway from the cavity into the interior of the patient. The methodfurther includes mating a connector to a proximal end of a catheter andinserting a distal end of the catheter through the second opening. Themethod further includes sliding the catheter through the second openinginto the interior of the patient and coupling the proximal end of thecatheter and the connector to the second opening thereby disposing theconnector substantially within the cavity and sealing the second openingand creating a fluid path from the interior of the patient to theconnector. The method further includes connecting a first deviceexternal to the patient to the connector through the first opening.

In one embodiment, the method further includes anchoring the housingwithin the patient with sutures. The sutures include subcutaneoussutures

In another embodiment, the method further includes anchoring the housingwithin the patient with subcutaneous hooks.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

FIG. 1 is an illustrative perspective side view of a percutaneous accessdevice according to one embodiment of the invention.

FIG. 2 is an illustrative top view of the percutaneous access deviceshown in FIG. 1.

FIG. 3 is an illustrative perspective view of the percutaneous accessdevice shown in FIG. 1.

FIG. 4 is an illustrative perspective front view of the percutaneousaccess device shown in FIG. 1.

FIG. 5 is an illustrative cross-sectional side view of a percutaneousaccess device according to another embodiment of the invention.

FIG. 6 is an illustrative cross-sectional side view of the percutaneousaccess device of FIG. 5, implanted in a patient.

FIG. 7 is an illustrative cross-sectional side view of the percutaneousaccess device shown in FIG. 5, implanted in a patient and connected toan external medical device.

FIG. 8A is an illustrative cross-sectional view of a connector-catheterconnection including a valve in a closed position according to oneembodiment of the invention.

FIG. 8B is an illustrative cross-sectional view of theconnector-catheter connection shown in FIG. 8A, including the valve inan open position.

FIG. 9A is an illustrative cross-sectional view of a percutaneous accessdevice including a pivoting luer connector in an open position,according to one embodiment of the invention.

FIG. 9B is an illustrative cross-sectional view of the percutaneousaccess device shown in FIG. 9A, with the pivoting luer connector in aclosed position.

FIG. 10A is an illustrative cross-section view of a percutaneous accessdevice including a telescopic luer connector in an extended position,according to one embodiment of the invention.

FIG. 10B is an illustrative cross-section view of a percutaneous accessdevice including a telescopic luer connector in a retracted position,according to one embodiment of the invention.

FIG. 11 is an illustrative top view of a percutaneous access deviceaccording to another embodiment of the invention.

FIG. 12 is an illustrative cross-sectional side view of the percutaneousaccess device of FIG. 11.

FIG. 13 is an illustrative top view of the percutaneous access deviceincluding two connectors, according to another embodiment of theinvention.

FIG. 14 is an illustrative cross-sectional side view of the percutaneousaccess device shown in FIG. 11, implanted in a patient and connected tointernally-implanted medical devices.

FIG. 15A is an illustrative top view of a housing cover, according toone embodiment of the invention.

FIG. 15B is an illustrative cross-sectional side view of a housingincluding the housing cover shown in FIG. 15A.

FIG. 16A is an illustrative diagram of a percutaneous access deviceimplanted in a patient and connected to internal and external medicaldevices, according to one embodiment of the invention.

FIG. 16B is an illustrative diagram of the percutaneous access deviceshown in FIG. 16A, implanted in a patient and connected to internalmedical devices.

FIG. 17A is an illustrative top view of a housing cover with anelliptical shape, according to one embodiment of the invention.

FIG. 17B is an illustrative top view of a housing cover with an canoeshape, according to another embodiment of the invention.

FIG. 17C is an illustrative top view of a housing cover with an almondshape, according to yet another embodiment of the invention.

DESCRIPTION

The invention relates generally to percutaneous access, and morespecifically to methods and devices associated with percutaneous access.In one embodiment, an access device allows physicians and/or othermedical personnel to obtain long term percutaneous access to theinterior of a patient's body. The access device reduces the opportunityfor infection by completely shielding fluid connections (that extendinto the interior of the patient's body) from the patient's skin andfrom the external environment. The access device has no protrudingexternal elements, and can be protected by a low-profile cover that issubstantially flush with the patient's skin. The access device thus iscosmetically appealing and allows substantially normal physicalactivity. The cover is difficult to remove accidentally or intentionallyfrom the access device. The access device allows access to the interiorof the patient without requiring a needle to pierce the skin. Further,internal components, such as a catheter or a valve, can be replacedwithout a surgical procedure.

Referring to FIGS. 1-4, in one embodiment, a medical device for allowingpercutaneous access to a patient's body is an access device 100 whichincludes a housing 112, a cavity 110, a first opening 116, a flange 102,a second opening 114, and a connector 104. The housing 112 defines thecavity 110, the first opening 116 (which leads into the cavity 110), andthe second opening 114 (which also leads into the cavity 110).

The housing 112 is implanted in a patient to dispose the cavity 110subcutaneously within the patient. After the housing 112 is implanted inthe patient, the first opening 116 is substantially flush with thesurface of the skin of the patient and creates a percutaneous passagewayfrom the exterior of the skin of the patient into the cavity 110. Thesecond opening 114 creates a passageway from the cavity 110 into theinterior of the patient. The connector 104 is coupled to the secondopening 114 and is disposed substantially within the cavity 110. Theconnector 104 allows a first device which is external to the patient,such as an infusion pump for example, to be connected to a second devicedisposed within the interior of the patient, such as a catheter 106 forexample. The flange 102, which is coupled to the housing 112, holds thehousing 112 in place once the housing 112 is implanted in a patient. Inone embodiment, the housing 112 is made of a bio-compatible materialsuch as Polysulfone or Titanium. The housing 112 can also be made of amolded bio-compatible plastic material. In another embodiment, thehousing 112 can made of a soft material that can be penetrated bysutures or needles. In some embodiments, the housing 112 is canoeshaped, elliptically shaped, or almond shaped, as indicated in FIGS.17A, 17B, and 17C. In other embodiment, the housing 112 includes aconcave bottom, as indicated in FIG. 5 and in still other embodimentsthe housing 112 include a flat bottom, as indicated in FIG. 1.

Referring to FIG. 5, in one embodiment, the connector 104 is a luerconnector and is coupled to the second opening 114 and the catheter 106.A proximal end 516 of the catheter 106 is first positioned over a distalend 506 of the connector 104. The catheter is held in place over theconnector 104 by a plurality of barbs 504 (or a raised ring) on thedistal end 506 of the connector 104. The distal end 506 of the catheter106 is fed through the opening 114 until the plurality of barbs 504 onthe distal end 506 of the connector 104 engage a plurality of barbs 512within the second opening 114. The connector 104 is secured in place byengaging the plurality of barbs 504 with the plurality of barbs 512.After the connector 104 is secured in place, the connector 104 ispositioned such that the connector 104 is disposed substantially withinthe cavity 110. Specifically, in some embodiments, a small portion ofthe connector 104 can extend out of the first opening 116. However, inother embodiments, no portion of the connector 104 extends out of thefirst opening 116 and is disposed entirely within the cavity 110. Insome embodiments, the connector 106 is sealable when not in use. Forexample, the connector 106 can have a threaded or friction fit sealingcap that is removed during use and replaced when not in use. The cap canalso include a penetrable surface, such as rubber or silicone forexample, which can be penetrated by a needle. Further, the connector 106can include a valve 518 which opens when the connector 106 is connectedto an external device and closes when the connector 106 is disconnectedfrom the external device. In some embodiments, the value 518 can be aslit valve made of foam or rubber. The connector 106 is also compatiblewith typical medical luer attachments. In other embodiments, theconnector 104 and the catheter 106 can include a single lumen ormultiple lumens.

Referring to FIGS. 1 and 6, in one embodiment, the percutaneous accessdevice 100 is implanted into a patient 604 as follows. First, a linearincision is made in the patient. Such an incision is less traumatic tothe patient (as opposed to coring). A distal end of a guidewire isinserted through the incision, into the patient 604, and into an area inwhich the catheter 106 is to be placed, such as vein for example. Ifnecessary, a dilator may be placed over the guidewire to dilate the areawhere the catheter 106 is to be inserted. A proximal end of theguidewire is inserted through the second opening 114 and the housing 112is then inserted into the patient 604 through the incision. The housing112 is positioned so that the second opening 114 is axially aligned withthe guidewire, the flange 102 is subcutaneous, and the first opening 116is substantially flush with the surface of the patient's skin 604. Theflange 102 promotes stability of the housing 112 and adhesion of theskin and subdermal layers immediately adjacent to the incision site. Insome embodiments, subcutaneous sutures sewn through holes in the flange102 can be used to anchor the subdermal layers to the flange 102. Inother embodiments subcutaneous hooks may be used to anchor the subdermallayers to the flange 102. In still other embodiments, the flange 102 canbe coated with materials that promote tissue growth to provide bettersealing of the incision, such as collagen or other tissue growthcatalysts, for example. Materials that promote ingrowth of cells, suchas a permeable fabric, a textured polymer, or a steel mesh can also bebonded to or embedded in the flange 102. The added ingrowth materialscause the skin surrounding the flange 102 to bond securely with theflange 102. The surface of the patient's skin 604 may also be secured tothe housing 112 by using glue, such as Dermabond (a trademark of and aproduct commercially available from Closure Medical Corporation ofRaleigh, N.C.) or medical tape around the incision site.

After the housing 112 is anchored in place, the distal end 514 of thecatheter 106 is inserted through the second opening 114 over theguidewire and fed into the patient. Next, the guidewire is removed andthe proximal end 516 of the catheter 106 is coupled to the distal end506 of the connector 104 and the distal end 506 of the connector 104 isfed through the opening 114 and secured in place (as previouslydescribed) thereby sealing the opening 114 and creating a fluid path 502from the interior of the patient to the connector 104.

The implanted access device 100 can then be covered with a temporarydressing or Tegaderm (a trademark of and a product commerciallyavailable from 3M Health Care Ltd. of Loughborough, UK) which is askin-like bandage. The cavity 110 can also be filed with gauze and/orantimicrobial agents. In another embodiment, the housing 112 can becovered with a low-profile, housing cover 602, which can be shaped toconform to the contour of the patient's skin. The housing cover 602couples to an edge 108 of the housing 112 and creates a watertight sealand protects the connector 106 and the cavity 110 from debris and damagefrom the environment. In some embodiments, the housing cover 602includes a locking mechanism which prevents the housing cover 602 frombeing accidentally or intentionally removed by the patient. For example,the housing cover 602 can be secured to the housing 112 by using afriction fit or a thread fit. The housing cover 602 can also be securedto the housing 112 using clamps that clamp onto the edge 108. The clampscan be configured to selectively engage and disengage the edge 108 whena key is inserted into the housing cover and turned. In otherembodiments, the housing cover 602 can be coupled to the housing 112with a wire or a hinge, for example. Additionally, gauze can be placedaround the first opening 116 between the patient's skin and the housingcover 602.

In another embodiment, after the linear incision is made, the guidewireis inserted into the vein (or other organ) and then the distal end 514of the catheter 106 is inserted into the vein over the guidewire. Next,the proximal end 516 of the catheter is inserted into the second opening114 and fed into the housing 112. The guidewire is removed and thedistal end 506 of the connector 104 is then coupled to the proximal end516 of the catheter and then fed through the opening 114 and secured.The housing 112 is then implanted into the patient using the procedurepreviously described.

Referring to FIGS. 6 and 7, the connector 104 is accessed by firstremoving the housing cover 602. Next, an external medical device, suchas a connection tube 702 to an infusion pump, is connected to theconnector 104 creating a fluid connection 502 through opening 118. Afterthe procedure utilizing the infusion pump has been completed, theconnection tube 702 is disconnected from the connector 104 and thehousing cover 602 is placed back on the housing 112 to seal the cavity110 and protect the connector 104. The access device 100 can be usedwith a variety of other medical devices, such as body fluid removaldevices and blood purification devices, for example.

The access device 100, after initial surgical implantation, enablesphysicians and/or other medical personnel to repeatedly (and withoutfurther surgery) access various internal regions of the patient, such asveins, arteries, and various organs for example. The connector 104 andfluid connection that extends into the patient's body is shielded fromthe patient's skin and from the external environment, and therebyreduces opportunity for infection. The access device 100 has noprotruding external elements, and can be protected by the low-profilehousing cover 602 which is substantially flush with the patient's skinand thereby allows the patient to engage in substantially normalphysical activity.

Referring again to FIGS. 5 and 6, if the access device 100 remainsimplanted for an extended period of time, the connector 104 and/or thecatheter 106 may need to be replaced. Replacement of these componentscan be achieved without surgery. First, the housing cover 602 is removedfrom the housing 112. Next, the connector 104 is removed from the secondopening 114 and the connector 104 is decoupled from the catheter 106. Aguidewire is fed through the catheter into the patient. The catheter 106is then removed from the patient. A new catheter 106 is inserted intothe patient over the guidewire through the second opening 114 and theguidewire is then removed. A new connector 104 is coupled to thecatheter 106 and secured in the second opening 114 as previouslydescribed. A benefit of this feature is that the connector 104 and/orthe catheter 106 can be replaced without surgery, resulting in lesstrauma to the patient and reduced chance of infection.

Referring to FIGS. 8A and 8B, in another embodiment, the connector 104is a luer connector and is coupled to the second opening 114 and thecatheter 106. A proximal end 516 of the catheter 106 is first positionedover a distal end 506 of the connector 104. The catheter 106 is held inplace over the connector 104 by a plurality of barbs 804 (or a rings) onthe distal end 506 of the connector 104. The distal end of the catheter106 is fed through the opening 114 until the plurality of barbs 504 onthe distal end 506 of the connector 104 meet a plurality of O-rings 802.The connector 104 is secured in place by engaging the plurality of barbs504 with the plurality of O-ring 802. After the connector 104 is securedin place, the connector 104 is positioned such that the entire connector104 is disposed entirely within the cavity 110. The connector 104 alsoincludes a threaded locking cap 808 which engages threads 806. Thelocking cap 808 is used to secure a connection between the connector 104and an external medical device. The connector 104 can also include avalve 810 which remains sealed when no external medical device isconnected to the connector 104 and opens when the connector 104 isconnected to an external medical device, such as a connection tube 812to an infusion pump.

Referring to FIGS. 9A and 9B, in another embodiment, the access device100 includes a pivoting luer connector 902. The pivoting luer connector902, when pivoted to a first position, opens the fluid path 502 throughthe second opening 114 and, when pivoted to a second position, closesthe fluid path 502 through the second opening 114. In operation, whenthe pivoting luer connector 902 is not in use, the pivoting luerconnector 902 is pivoted to the second position thereby keeping thefluid path 502 closed. The pivoting luer connector 902 is only pivotedto the first position after an external medical device has beenconnected to the pivoting connector 902.

Referring to FIGS. 10A and 10B, in still another embodiment, the accessdevice 100 includes a telescopic luer connector 1002. The telescopicconnector 1002, when not in use, is disposed entirely within the cavity110. However, when the telescopic connector 1002 is in use, thetelescopic connector 1002 can be extended out of the cavity 110 to allowa physician or other medical personnel to connect an external medicaldevice more easily. In another embodiment, the telescopic connector 1002includes a stop or plug disposed inside the connector 1002. The stop iscoaxial with the opening 118 and acts as a valve which seals the opening118 when the telescopic connector is 1002 is retracted. When thetelescopic connector 1002 is extended, the seal between the opening 118and the stop is broken thereby allowing fluid to flow past the stop andthrough the opening 118.

Referring to FIG. 13, in other embodiments, the access device 100includes two luer connectors 1304 a and 1304 b and two correspondingcatheters 1302 a and 1302 b. In this configuration, blood, for example,can be easily drawn out of a patient, purified, and put back into thepatient. In another embodiment, the access device 100 includes two luerconnections that both connect to a single catheter. The single cathetera single lumen catheter or multilumen catheter.

In other embodiment, the access device 100 includes a luer connectorwith a pressure-responsive slit valve. The valve includes a diaphragmincluding a slit which is flexed in one direction by hydrostaticpressure and flexed in an opposite direction by negative pressure toselectively open the slit. Examples of such a pressure-responsive slitvalves are shown in U.S. Pat. No. 5,205,834, U.S. Pat. No. 5,201,722,and U.S. Pat. No. 5,169,393 which are herein incorporated by reference.

Referring to FIGS. 11, 12, and 14, in another embodiment, the cavity 110of the access device 100 is used to store a small printed circuit board1102 including electronics 1108 and/or a battery 1106 used inconjunction with one or more medical devices implanted in a patient,such as a pacemaker 1402 and/or a sensor 1404, for example. In thisconfiguration, the connector 104 is an electrical connector. Theconnector 104 is positioned such that the connector 104 is disposedsubstantially within the cavity 110. Specifically, in some embodiments,a small portion of the connector 104 can extend out of the first opening116. However, in other embodiments, no portion of the connector 104extends out of the first opening 116 and is disposed entirely within thecavity 110.

Wires (or optical fiber) 1202 from the connector 104 extendsubcutaneously from the housing 112 and connect to the pacemaker 1402and/or sensor 1404. Wires (or optical fiber) 1104 extending from theconnector 104 inside the cavity 110 connect to a connector 1110 on theprinted circuit board 1102. The printed circuit bard 1102 is coupled tothe housing 112 inside the cavity 110 by mounting posts 1204.

Referring to FIG. 16B, in one embodiment, an infusion pump 1616 and amedication reservoir 1618 can be housed in the cavity 110 of the accessdevice 100. The medication reservoir 1618 supplies medication to theinfusion pump 1616 through tube 1620. The infusion pump 1616 pumpsmedication though tube 1622, through luer connector 1626, and throughcatheter 1628 and into the patient's body 604. Electronics 1614 (housedin the cavity 110) can include a battery to power the infusion pump 1616and control circuitry to control the infusion pump 1616. In addition tothe luer connector 1626, the access device 100 can also include one ormore electronic connectors, such as electrical connector 1630.Electronic connector 1630 can be used to connect power and controlelectronics to a sensor 1624, or other device (via wires or opticalfiber 1626) implanted in the patient, for example. In anotherembodiment, the entire cavity 110 can be used as a medication reservoir.

Referring to FIG. 14, in another embodiment, the printed circuit board1102 (housed in the cavity 110) can include control circuitry 1108 and abattery 110 to control and power a pacemaker 1402 implanted in apatient's body 604. In this configuration, the battery 1110 can bereplaced without surgery by simply removing the housing cover 602,replacing the battery 1110, and then replacing the cover 602. Similarly,the electronics 1108 controlling the pacemaker 1402 can also be repairedand/or adjusted with surgery. In other embodiments, the wires 1202extending into the patent's body 604, can fan out to connect to multiplemedical devices such as the pacemaker 1402 and one or more sensors 1404.In still other embodiments, the access device 100 can include multipleelectronic connectors 104.

As previously described, the electronics 1108 on the printed circuitboard 1102 can include control and memory electronics for varioussensors, such as pressure sensors and urine pH sensors for example. Inanother embodiment, these sensors (along with control circuitry andpower) can be housed in the cavity 100, and the fluid to be analyzed(blood or urine, for example) is brought into the cavity 100 via aninlet luer connector and pumped back into the body via an outlet luerconnector.

Referring to FIG. 16A, in still another embodiment, the access housing100 can include any combination of connectors. For example, the accesshousing 100 can include an inlet luer connector 1638 and an outlet luerconnector 1636. The inlet connector 1638 is connected to a catheter 1632which is also connected to a vein 1602. The outlet connector 1636 isconnected to a catheter 1634 which is also connected to the vein 1602.The inlet connector 1638 is also connected to tube 1606 which isconnected to a blood purification device 1608 external to the patient604. The outlet connector 1636 is also connected to a tube 1604 which isalso connected to the blood purification device 1608. In operation, theblood purification device 1608 draws blood through the catheter 1632,through the inlet connector 1638, through the tube 1606 and into theblood purification device. After the blood is purified, the bloodpurification device 1608 pumps the purified blood through tube 1604,through outlet connector 1636, through catheter 1634 and back into thevein 1602. Further, the access device 100 can include an electronicconnector 1640 which connects control and power electronics 1612 to amedical device (via wires or optical fiber 1642) such as a blood presssensor 1610 implanted in the patient 604.

In another embodiment, the cavity 110 of the access device 100 can beconfigured to house various electro-mechanical components of anartificial heart implanted in a patient. In this embodiment, theelectro-mechanical parts are accessible (without requiring surgery) byremoving the housing cover 602.

In other embodiments, the access device 100 can include electronicscapable of wireless communication. In this embodiment, physicians and/ormedical personnel can wirelessly communicate with electronics stored inthe cavity 110 (without removing the cover 602) to download data fromvarious sensors implanted in a patient, for example. The physician canalso download a status of a medication reservoir or a status of batterypower. Further, the electronics housed in the cavity used to communicatewith and control various implanted medical devices can do so wirelessly.For example, a sensor used for sensing the pressure in a particularartery can transmit sensor data wirelessly to an electronic storageelement in the cavity 110, or control circuitry used for controlling apacemaker can transmit control signals wirelessly to the pacemaker.

In another embodiment, sensor signals can be transmitted through afluid. For example, a pressure sensor is housed within the cavity 110.The sensor is in physical communication with a proximal portion of anelongated membrane that contains a fluid. The elongated membrane extendsoutside the cavity 110 into the interior of the patient. A pressurechange in the patient causes pressure on a distal portion of themembrane which, in turn, causes the fluid within the membrane to flowback to the proximal portion of the membrane and be detected by thepressure sensor.

Referring to FIGS. 15A and 15B, in another embodiment, the housing cover602 can include low-profile electronic connectors 1506 and/or fiberoptics connectors 1508 which can be used to access and read out sensordata stored in a memory chip on the printed circuit board 1102 withouthaving to remove the housing cover 602. The housing cover 602 can alsoinclude a low-profile luer connector 1510 which enables a fluidconnection to the cavity 110. Such a fluid connection enables aphysician and/or medical personnel to access a medical device implantedin the patient (through the cavity 110) or refill a medication reservoirwithin the cavity 110 without having to remove the housing cover 602.Further, the housing cover 602 can also include indicator LEDs 1502 toindicate low battery power or low medication reservoir levels, forexample. The housing cover 602 can also include a battery connector 1502to enable recharging of a battery 1110 stored in the cavity 110 withouthaving to remove the cover 602. The housing cover 602 can also include alow-profile liquid crystal or LED display for reading sensor data,providing a status of battery power, or providing a status of amedication reservoir stored in the cavity 110, for example. Moreover,the housing cover 602 can include an infrared or wireless communicationport 1514 to allow wireless communication with electronics stored withinthe cavity 110 and/or medical devices implanted in the patient.

Some of the benefits of utilizing the access device 100 to store suchelectronics and/or batteries include nonsurgical accessibility of theelectronics for repair and/or replacement, nonsurgical batteryreplacement, patient comfort, and reduced chance of infection fromelectronic components.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention.Accordingly, the invention is not to be defined solely by the precedingillustrative description.

1. An access port for implantation into a patient, comprising: a housingdefining a cavity therein, the housing including a first openingextending from an exterior of the housing to the cavity and a secondopening extending from an exterior of the housing to the cavity wherein,when implanted in the body in an operative position, the first openingfaces a skin of the patient and the second opening faces away from theskin toward an interior of the patient; a removable connector includinga distal end sized to be received within an access device, the removableconnector including a locking element which, when the removableconnector is received within the second opening, locks the removableconnector to the housing.
 2. The access port according to claim 1,further comprising a cover sealing the first opening when access to theaccess device is not desired.
 3. The access port according to claim 2,wherein the cover is shaped to substantially conform to a shape of aportion of skin surrounding the first opening.
 4. The access portaccording to claim 2, wherein the cap includes a lock for locking thecap in place on the housing.
 5. The access port according to claim 1,wherein the removable connector comprises a connection tube.
 6. Theaccess port according to claim 1, wherein the locking element includesat least one projection which mates with a corresponding projection on asurface of the housing adjacent to the second opening.
 7. The accessport according to claim 1, wherein the removable connector furthercomprises a cap selectively opening and closing an opening of theremovable connector.
 8. The access port according to claim 1, whereinthe removable connector is telescopic for extension out of the cavity toestablish access to the access device.
 9. The access port according toclaim 1, wherein the housing is substantially elliptical.
 10. The accessport according to claim 1, wherein the removable connector includes avalve and an extension portion wherein, when the valve is in a firstposition, a lumen of the valve is aligned with a lumen of the extensionportion and, when in a second position, the lumen of the valve is sealedfrom the lumen of the extension portion.
 11. The access port accordingto claim 10, wherein the valve pivots between the first and secondpositions.
 12. A method of accessing areas within a patient's skin,comprising: making an incision through the patient's skin; implantingthrough the incision a port with a cavity formed therein, the portincluding a first opening extending from an exterior thereof to thecavity and a second opening extending from an exterior thereof to thecavity, the port being implanted so that the first opening faces theskin and the second opening faces away from the skin toward an interiorof the patient; and inserting into the second opening a connectoradapted to couple to an access device.
 13. The method according to claim12, wherein the incision is a substantially straight incision.
 14. Themethod according to claim 12, further comprising the step of locking theconnector to the port.
 15. The method according to claim 14, wherein theconnector is locked to the port by engaging a projection on theconnector with a corresponding projection on the port.